Kornimate/medical-research-clean huggingface dataset:
clinical study on the effect of zhenyuan capsule on cardiopulmonary function in patients with scad

Conditions: Stable Coronary Heart Disease

Summary: a randomized, double-blind, placebo trial was adopted, and cardiopulmonary exercise load test (cpet) was used to detect peak oxygen uptake (peakvo2) and exercise metabolic equivalent (mets) to confirm the clinical effect of zhenyuan capsule on improving cardiopulmonary endurance in patients with coronary heart disease of qi deficiency and blood stasis.


Eligibility criteria:
inclusion criteria: * results of coronary angiography or spiral ct:patients with coronary artery stenosis ≥ 50%, or with a clear history of myocardial infarction, or stable condition more than one month after acs treatment (percutaneous coronary intervention therapy, pci, coronary artery bypass graft, cabg)； * lvef≥40%； * angina grade ⅰ-ⅱ (ccs grade); * the syndrome differentiation of traditional chinese medicine is the syndrome of qi deficiency and blood stasis； * 18 years old ≤ age ≤ 75 years old； * in accordance with the risk stratification of cardiac rehabilitation in patients with coronary heart disease, the patients with moderate and low risk can carry out cardiopulmonary rehabilitation by exercise； * those who sign the informed consent form. exclusion criteria: * patients with acute myocardial infarction or unstable angina pectoris, or within one month after pci or cabg; * patients with absolute and relative contraindications in accordance with cardiopulmonary exercise test; * patients who took zhenyuan capsule in the past 1 month or participated in other clinical trials in the past 1 month； * renal insufficiency, serum creatinine \> 2.5mg / dl in male and \> 2.0mg/dl in female； * patients with obvious liver disease or both alt and ast were 3 times higher than the normal upper limit； * new york heart function (nyha) grade iv, or patients with recurrent malignant arrhythmias; * complicated with chronic obstructive pulmonary disease or even respiratory failure, or complicated with pulmonary infection; * diabetic patients with random blood glucose ≥ 13.7mmol/l or glycosylated hemoglobin ≥ 9.5%; * pregnant or preparing pregnant women, lactating women; * patients with acute cerebrovascular diseases; malignant tumors or patients with life expectancy of less than 1 year; patients with severe hematopoietic diseases; patients with severe mental illness; * for those who are allergic to the known ingredients of the drug.
nordic pancreatic cancer trial (norpact) - 1

Conditions: Pancreatic Cancer

Summary: this study evaluate the additional effect of adding chemotherapy prior to resection of a pancreatic head malignancy. the patients will be randomized into two groups; surgery first (control group) and neoadjuvant chemotherapy (intervention). primary endpoint is overall survival after resection

pancreatic cancer is the fourth leading cause of cancer-related deaths in europe and the united states. surgical resection remains the only potentially curative treatment. however, the median survival of patients undergoing pancreatic resection alone is 16-23 months. the administration of adjuvant chemotherapy leads to an improvement in overall survival. thus, completion of multimodality treatment (mmt) is the ideal goal and standard of care for treatment of pancreatic ductal adenocarcinoma (pdac). currently, the surgery-first (sf) strategy is the most universally accepted approach to resectable pdac (and is the standard of care in norway), but the optimal sequence of surgery and chemotherapy remains unclear. the purpose of this study is to further investigate the additional efficacy of neoadjuvant chemotherapy to the standard treatment for resectable cancer of the pancreatic head (surgery followed by adjuvant chemotherapy).

Eligibility criteria:
inclusion criteria: * resectable adenocarcinoma of the pancreatic head * t1-3, nx, m0 (uicc 7th version, 2010) * cytologic or histologic confirmation of adenocarcinoma * age \> 18 year and considered fit for major surgery * written informed consent * considered able to receive the study specific chemotherapy exclusion criteria: * co-morbidity precluding pancreaticoduodenectomy * chronic neuropathy ≥ grade 2 * who performance score \> 2 • granulocyte count \< 1500 per cubic millimetre * platelet count \< 100 000 per cubic millimeter * serum creatinine \> 1.5 unl (upper limit normal range) * albumin \< 2,5 g/dl * female patients in child bearing age not using adequate contraception, pregnant or lactating women • mental or organic disorders which could interfere with informed consent or treatments * other malignancy within the past 5 years, except non-melanomatous skin or non-invasive cervical cancer * percutaneous tumor biopsy * any reason why, in the opinion of the investigator, the patient should not participate * pregnancy * breastfeeding

Keywords: neoadjuvant treatment
assessment of clinical outcomes in closure of deep neck space infection incisions

Conditions: Deep Neck Space Infections

Summary: the purpose of this study is to determine if closure of deep neck infection incisions at the time of extraoral drain removal has any impact on rates of reinfection and to determine if this treatment will have any impact on scar formation and qualitative measures of pain or impact on quality of life during the post-operative healing period.


Eligibility criteria:
inclusion criteria: * deep neck space infection * who require a conservative unilateral submandibular neck incision to access affected deep fascial neck spaces exclusion criteria: * pregnant females * cognitively impaired individuals * deep neck space infections which require bilateral neck incisions, large neck apron incisions, or placement of negative pressure therapy.
effect of nutritional formula supplementation on growth rate of growth hormone (gh) treated children with growth hormone deficiency (ghd) after the second year of therapy

Conditions: IGHD - Isolated Growth Hormone Deficiency; Growth Retardation

Summary: the proposed study is a double blind, randomized, placebo controlled study the aim of the study is to evaluate the effect of combined growth hormone (gh) treatment \& nutritional formula supplementation versus gh \& placebo on growth parameters in 64 children with isolated growth hormone deficiency (ighd) after the 2nd year of gh treatment. in this trial gh is a background treatment (non-investigational medicinal product. participants may be treated with any of the commercial gh products approved in israel for the indication of ighd. participants will be randomly assigned either to the intervention group or the placebo control group. randomization for the two study groups will be made in a ratio of 1:1. both participants and study team will be blinded to the type of treatment that each patient will receive during the study. the randomization will be done according to gender and tanner stage. participants in the intervention groups will be treated with the study formulas and participants in the control group will be treated with a placebo low caloric formulas (powder added to water) the study will continue for 6 months of intervention versus active placebo, with additional 6 months (an extension period), in which participants at both groups, the intervention and the placebo, will be offered to continue their participation in the study with the active study supplement.


Eligibility criteria:
inclusion criteria: * gh treatment for at least 24 months due to ighd. confirmed diagnosis of ghd as determined by at least one gh stimulation test, defined as a peak gh level of ≤ 10 ng/ml * boys: testicular volume \< 8ml; girls: breast ≤ tanner 3 * weight sds \< 0 * bmi sds \< 50 precentile for age and gender * signing inform consent forms exclusion criteria: * other indication for gh treatment. * bone age: boys\>13.5, girls\>11.5. * any known morbidity: chronic disease dysmorphic syndromes, bone diseases, organic brain diseases, neurological disease, past or current malignancy, chronic cardiac, renal or pulmonary problems, metabolic disorders. * any known gastrointestinal problem including absorption problems. * any chronic treatment with medication that might affect appetite, weight or growth (for example steroids) except from ritalin use * any eating disorders and/or psychiatric disorder
effect of photobiomodulation treatment in individuals with multiple sclerosis:

Conditions: Multiple Sclerosis

Summary: background: multiple sclerosis (ms) is an autoimmune disease, for which the forms of treatment are medication and rehabilitation. however, in vitro and in vivo studies have demonstrated that photobiomodulation can be an effective treatment modality for inflammatory diseases, including ms. photobiomodulation has a broad range of benefits, such as the avoidance of cell and tissue death, the stimulation of healing and injury repair, reductions in pain, edema and inflammation, cell proliferation and even apoptosis. the outcomes of photobiomodulation include the regeneration of cells, the stimulation of the growth of schwann cells, a reduction in spasticity, functional improvements, a reduction in nitric oxide levels and the upregulation of the cytokine il10, demonstrating that this therapeutic modality can offer neuro-protection. methods: a randomized, controlled, double-blind, clinical trial is proposed. the patients will be divided into six groups. groups 1 and 2 will receive sham and active photobiomodulation in the sublingual region, respectively. groups 3 and 4 will receive sham and active photobiomodulation along the spinal cord, respectively. group 5 will receive placebo treatment with photobiomodulation on the skin in the region of the radial artery with a specific bracelet. group 6 will be treated with photobiomodulation on the skin in the region of the radial artery with a specific bracelet. discussion: treatment for ms is directed at the immune response and slowing the progression of the disease. this is one of the first clinical trials with sublingual and along the spinal cord photobiomodulation, which could help establish a new, promising treatment of the disease associated with pharmacological treatment.


Eligibility criteria:
inclusion criteria: * diagnosis of ms; * age between 18 and 60 years; * currently undergoing pharmacological treatment; * capable of understanding and following verbal instructions; * score of \< 7 on the expanded disability status scale; * no restriction will be imposed regarding gender. exclusion criteria: * other autoimmune diseases; * neoplasias; * heart failure; * respiratory failure; * renal insufficiency; * hepatic insufficiency; * acquired immunodeficiency syndrome; * patients with relapses of the disease will be excluded from the study.
evaluation of biomarker levels in gingival crevicular fluid of patients with different periodontal diseases

Conditions: Periodontal Diseases

Summary: objectives: the aim of this study is; detection of peptidyl arginine deiminase4 (pad4), galectin-3 and tumor necrosis factor alpha (tnf-α) levels in gingival crevicular fluid (gcf) samples of periodontally healthy, gingivitis and periodontitis patients and the possible correlation between these values and clinical parameters of periodontal diseases. materials and methods: samples of gcf were obtained from 60systemically healthy non-smoker individuals with periodontitis (p, n=20), gingivitis(g, n=20) and healthy periodontium (s, n=20). full-mouth clinical periodontal measurements including probing depth (pd), clinical attachment level (cal), bleeding on probing (bop), gingival index (gi) and plaque index (pi) were also recorded. enzyme-linked immunosorbent assay (elisa) was used to determine pad4, galectin-3 and tnf-α levels in the biological samples.


Eligibility criteria:
inclusion criteria: * systemically healthy (the determination of healthy volunteers will be based on the statements of the patients in the anamnesis. no additional examinations will be made.) * at least twenty permanent teeth in the mouth * non-smoker * no medication for continuous use * those who have not used antibiotics, anti-inflammatory and systemic corticosteroid drugs in the last 6 months. * not in pregnancy or lactation period. * for the periodontitis group that has not received periodontal treatment in the last 6 months * for the periodontitis group; according to the evaluation made in 6 regions of each tooth, individuals with 30% or more bleeding on probing area, at least 2 teeth not adjacent to each quarter jaw with a depth of 5 mm or more and 4 mm or more attachment loss, coronal 1/3 and more on radiography (horizontal and / or vertical) bone loss * for the gingivitis group; according to the evaluation made in 6 regions of each tooth, individuals with 10% or more bleeding on probing area, having a probing depth of less than 4mm and no attachment loss * for healthy group; according to the evaluation made in 6 regions of each tooth,individuals with less than 10% bleeding on probing area, having a probing depth less than 4mm and no loss of attachment were included in the study. exclusion criteria: * any oral or systemic disease * regularly using a systemic medication * during pregnancy or lactation * received periodontal treatment within the last 6 months. * those who received antibiotic, anti-inflammatory or systemic corticosteroid medication in the last 6 months * smokers are not included in the study
metformin in prevention of lupus nephritis

Conditions: Lupus Nephritis

Summary: lupus nephritis (ln) is a main manifestation of systemic lupus erythematosus (sle), which will largely effect the prognosis of sle patients. our previous 10-year data showed that the development of ln is most common in the first year of sle, occupying about 17%. and our group has established a prediction model to predict the 1-year probability of ln for sle patients without renal involvement. our previous proof-of-concept trial and multicenter, randomized, double-blind, placebo-controlled trial indicated that metformin seemed to have potential to reduce the new-onset of ln in sle patients (unpublished data, in review). so the investigators tried to illustrate whether metformin has effect to prevent the development of lupus nephritis in high risk sle patients based on ln prediction model.


Eligibility criteria:
inclusion criteria: * new-onset of sle (within 1 year) * meet the 1997 acr criteria of sle * 1-year risk of developing ln higher than 50% based on ln prediction model. * all the patients received standard care of therapy. (mycophenolate/azathioprine/cyclosporin/tacrolimus/methotrexate/leflunomide were allowed). * sign the informed consent. exclusion criteria: * patients with kidney involvement at screening were excluded * patients with severe sle were excluded, such as neuropsychiatric and cardiac involvement * cyclophosphamide or biologics were not allowed. * alanine aminotransferase (alt)/ aspartate aminotransferase (ast) \> 2 times upper normal limits; creatinine clearance rate \< 60ml/min; * previous exposure of metformin within 30 days before screening; or previous history of intolerant to metformin; * patients who diagnosed of diabetes mellitus; * pregnancy or lactation.
long-term extension study of krn23 in adult subjects with x-linked hypophosphatemia (xlh)

Conditions: X-Linked Hypophosphatemia

Summary: the primary objectives of this study are to: * assess the long-term safety of krn23 subcutaneous (sc) administration in adult subjects with xlh * assess the proportion of subjects achieving serum phosphorus levels in the normal range (2.5-4.5 mg/dl) with long-term administration of krn23 * assess long-term pharmacodynamics (pd) of krn23 as measured by changes in the following: serum intact parathyroid hormone (ipth); serum and urinary phosphorus; ratio of renal tubular maximum phosphate reabsorption rate to glomerular filtration rate (tmp/gfr) and tubular reabsorption of phosphate (trp); serum 1,25-dihydroxy vitamin d (1,25\[oh\]2d); serum fibroblast growth factor 23 (fgf23); bone biomarkers: serum alkaline phosphatase (alp), bone-specific alp (balp), carboxy terminal crosslinked telopeptide of type i collagen (ctx), and procollagen type 1 n-terminal propeptide (p1np) * assess long-term immunogenicity of krn23 as measured by presence of anti-krn23 antibody (ada)


Eligibility criteria:
inclusion criteria: 1. have participated in kyowa hakko kirin pharma, inc.'s krn23-int-001 (nct01340482) or krn23-int-002 (nct01571596) studies (received at least 2 doses of krn23) 2. estimated glomerular filtration rate (egfr) ≥ 60 ml/min or egfr of 45 to \< 60 ml/min at screening with confirmation that the renal insufficiency was not due to nephrocalcinosis. 3. sexually active subjects must be willing to use an acceptable method of contraception (e.g., double barrier method) while participating in the study and for 30 days after receiving the last dose of krn23. exclusion criteria: 1. subject experienced a safety-related event in the krn23-int-001 or krn23-int-002 study that, in the opinion of the investigator and sponsor, precludes resuming krn23 treatment. 2. presence of nephrocalcinosis on renal ultrasound that, in the opinion of the investigator and sponsor, precludes resuming krn23 treatment. 3. pregnant or breastfeeding at screening or planning to become pregnant (self or partner) at any time during the study. 4. participation in an investigational drug or device trial within 30 days of enrollment (other than krn23-int-001 or krn23-int-002). 5. use of a pharmacologic vitamin d metabolite or analog (e.g., calcitriol, doxercalciferol, and paricalcitol), phosphate, or aluminum hydroxide antacids (e.g., maalox® and mylanta®) within 21 days prior to screening or during the study. 6. use of medication to suppress parathyroid hormone (pth) (e.g., sensipar®, cinacalcet, calcimimetics) within 2 months prior to screening.

Keywords: xlh fgf23 krn23
non traumatic neuro-vascular diseases critical complications : a prospective cohort study

Conditions: Non Traumatic Acute Brain Injury

Summary: the purpose of this observational epidemiological study is to investigate the management and the complications associated with non traumatic neuro-vascular diseases. data will be analysed to answer pre-defined scientific projects and to improve management of these conditions.

anonymous data will be collected by study coordinators in a secured e-database. cross audit will be performed to check data.

Eligibility criteria:
inclusion criteria: * non traumatic neuro-vascular diseases exclusion criteria: * consent withdrawal

Keywords: non traumatic acute brain injury
does showing video information about spinal anesthesia relieves patient anxiety?

Conditions: Anxiety; Surgery; Spinal Anesthesia

Summary: our primary aim is to compare the effect of pre-operative multimedia video information on perioperative anxiety and hemodynamic parameters.

anxiety is common in perioperative patients with incidence of 60-89 %. lack of knowledge about surgery and anesthesia, anesthesia procedures and unfamiliar surroundings are the common causes of anxiety . anxiety related to anesthesia can be due to lack of knowledge about its process, procedures and risk associated with it or misconceptions about it. long npo status and unexpected delay before and during anesthesia procedure and surgery further increases the anxiety in perioperative patients. anxiety increases the activity of sympathetic nervous system and cause preoperative and intraoperative tachycardia, hypertension, arrhythmias, increased pain perception and increase requirement of anaesthetic drugs. this may lead to harmful effect on patient health and decrease overall patient satisfaction and even traumatic experience for rest of life. this may affect process of giving informed consent for the planned surgery. many measures are taken to allay anxiety in perioperative patients. anxiolytic medications are given preoperative period to allay anxiety but they may have detrimental effect on patient health, requires administration under supervision of health professional and may not be effective unless the cause of anxiety is taken care. counselling regarding the procedure of anesthesia during pre-anesthetic check up is other way to allay anxiety but transfer of knowledge is usually limited and may not be entirely retained. other method in the form of written pamphlets, booklet or questionnaires have been tried but most of the patients in nepal are not literate enough to read and understand it. multimedia information to allay patient's anxiety has been successfully tried. previous study shows a significant reduction in anxiety level due to preoperative multimedia information among the patients undergoing surgery. investigators have developed a short visual clip of 4.5 minutes duration depicting the procedure of spinal anaesthesia .investigators will be using hamilton anxiety score in patients undergoing surgical procedures under spinal anesthesia .

Eligibility criteria:
inclusion criteria: - all patients between 18 and 65 years of age of either sex undergoing elective surgery under sab were included.only patients in asa category 1 and 2 will be included. exclusion criteria: * patients refusing to give consent for the study, * patients having significant cardiovascular or neurological disease, * patients on medications such as beta blockers, antidepressants, cardiac or psychiatric drugs, * pregnant patients and * patients those who had undergone procedures under sab in the past * patients facing any major complications after the surgery such as massive blood loss, having to convert to general anesthesia due to lengthy surgical procedure, patients requiring critical care administration after the surgery
prevalence of oral disorders in children in ent pathologies

Conditions: Eating Disorders; Language Disorders

Summary: many children have eating and verbal oral disorders. our research entitled: preora aims to study the prevalence of oral disorders presented in children consulting in ent department for three months (n = 2000). this first study will be carried out by passing the mch (montreal children's hospital) feeding scale, a self-questionnaire completed by the parents, in order to assess the presence of disorders according to the parents and will allow us to present oral disorders (score \> 70).

over a period of inclusion of 3 months, the doctors of the departement ont, robert debré hospital, will give written and oral information to the holders of parental authority and to the child at the beginning of the consultation. after a 15-minute reflection period (consultation time), if they agree to participate, parents will answer the doctor's questions and then complete the self-questionnaire.

Eligibility criteria:
inclusion criteria: * patients consulting at ent departement robert debré hospital * age 0-17 years * parents and children informed and given their oral consent for the study and speaking french exclusion criteria: * refusal of parents/children to participate

Keywords: eating disorders language disorders childhood